Obesity, Metabolic Syndrome, General Health, Diabetes

Digitally enhanced ketogenic diet versus low-fat diet for cardio-renal-metabolic health in a predominantly Hispanic adult population with overweight or obesity: Pilot randomised clinical trial

This 6‑month pilot RCT tested a digitally enhanced ketogenic diet (KD) versus a digitally enhanced low‑fat diet (LFD) in 60 predominantly Hispanic adults with overweight or obesity. Both groups received the same digital supports (asynchronous lessons, wearables, connected scale, app‑based self‑monitoring, and weekly personalized feedback). Participants measured capillary β-hydroxybutyrate daily for 2 weeks, then twice weekly. Primary aims were feasibility and preliminary efficacy on cardiorenal‑metabolic outcomes, with targeted plasma metabolites assayed to explore biomarker responsiveness.

Results:

• Weight & BMI (within groups): Both KD and LFD reduced weight and BMI at 3 and 6 months. Adjusted models estimated KD -12.1 lbs (5.5 kg) vs. LFD -8.6 lbs (3.9 kg) at 3 months, with similar magnitudes at 6 months; between‑group differences were not significant.
• Glycemia: HbA1c improved only in KD (6.0%→5.5% at 3 months, 5.7% at 6 months). LFD changes were not significant.
• Blood pressure: Systolic blood pressure (SBP) decreased in KD at 3 months (131.2→123.1 mmHg) but was not different between groups overall; LFD changes were not significant.
• Lipids: Triglycerides decreased in both groups (significant at 3 months in each). HDL rose by 6 months and LDL rose at 3 months in KD, with no significant between‑group differences.
• Metabolites: Broad decreases across branched‑chain, aromatic, and other amino acid–related metabolites occurred in both groups (21/29 metabolites at 3 months; 22/29 at 6 months), suggesting sensitive biomarker responses to lifestyle change.
• Ketones: The only between‑group difference was higher β‑hydroxybutyrate in KD at 3 months; self‑monitored ketosis frequency declined over time.

Overall, digitally delivered lifestyle support was feasible in this predominantly Hispanic cohort. Both KD and LFD produced weight loss and favorable triglyceride changes; KD showed within‑group improvements in HbA1c and short‑term SBP. However, apart from ketone levels, no clinical or metabolite outcomes differed significantly between diets, underscoring the need for larger, longer trials that integrate digital tools with metabolite feedback to personalize adherence and treatment effects